Modular heart valve prosthesis

ABSTRACT

A modular heart valve prosthesis includes a first heart valve device and a second heart valve device. The first heart valve device includes a first valve support including a first prosthetic valve disposed within the valve support, and an anchoring frame surrounding the first valve support and coupled to the first valve support. The first prosthetic valve includes synthetic fabric leaflets having a first thickness. The second heart valve device includes a second valve support including a second prosthetic valve disposed within the second valve support. The second prosthetic valve includes tissue leaflets having a second thickness, wherein the second thickness is greater than the first thickness. In a first configuration, the second heart valve device is separate from the first heart valve device, and in a second configuration, the second heart valve device is disposed within the first valve support of the first heart valve device.

FIELD OF THE INVENTION

The present invention relates to prostheses and methods formanufacturing prostheses. More particularly, the present inventionrelates to a structural component such as a stent, stent ring or frameof a prosthesis such as a stent-graft prosthesis or a heart valveprosthesis.

BACKGROUND OF THE INVENTION

The human heart is a four chambered, muscular organ that provides bloodcirculation through the body during a cardiac cycle. The four mainchambers include the right atrium and right ventricle which supplies thepulmonary circulation, and the left atrium and left ventricle whichsupplies oxygenated blood received from the lungs to the remaining body.To ensure that blood flows in one direction through the heart,atrioventricular valves (tricuspid and mitral valves) are presentbetween the junctions of the atrium and the ventricles, and semi-lunarvalves (pulmonary valve and aortic valve) govern the exits of theventricles leading to the lungs and the rest of the body. These valvescontain leaflets or cusps that open and shut in response to bloodpressure changes caused by the contraction and relaxation of the heartchambers. The leaflets move apart from each other to open and allowblood to flow downstream of the valve, and coapt to close and preventbackflow or regurgitation in an upstream manner.

Diseases associated with heart valves, such as those caused by damage ora defect, can include stenosis and valvular insufficiency orregurgitation. For example, valvular stenosis causes the valve to becomenarrowed and hardened which can prevent blood flow to a downstream heartchamber from occurring at the proper flow rate and may cause the heartto work harder to pump the blood through the diseased valve. Valvularinsufficiency or regurgitation occurs when the valve does not closecompletely, allowing blood to flow backwards, thereby causing the heartto be less efficient. A diseased or damaged valve, which can becongenital, age-related, drug-induced, or in some instances, caused byinfection, can result in an enlarged, thickened heart that loseselasticity and efficiency. Some symptoms of heart valve diseases caninclude weakness, shortness of breath, dizziness, fainting,palpitations, anemia and edema, and blood clots which can increase thelikelihood of stroke or pulmonary embolism. Symptoms can often be severeenough to be debilitating and/or life threatening.

Heart valve prostheses have been developed for repair and replacement ofdiseased and/or damaged heart valves. Such heart valve prostheses can bepercutaneously delivered and deployed at the site of the diseased heartvalve through catheter-based delivery systems. Such heart valveprostheses can be delivered while in a radially compressed configurationso that the valve prosthesis can be advanced through the patient'svasculature. Once positioned at the treatment site, the valve prosthesiscan be expanded to engage tissue at the diseased heart valve region to,for instance, hold the valve prosthesis in position. While these valveprostheses offer minimally invasive methods for heart valve repairand/or replacement, challenges remain to providing effective, lessinvasive, smaller crossing profile prosthetic delivery systems. Recentheart valve prosthesis designs have incorporated additional graftmaterial to aid in sealing to prevent paravalvular leakage (PVL).However, this additional material adds to the crossing profile of theheart valve prosthesis. The increased crossing profile, especially forradial interventions and inter-atrial septum puncture, limits the sizeof the heart valve prosthesis and/or the feasibility of transcatheterdelivery.

In an example, as a heart valve prosthesis is compressed/loaded fordelivery, portions of the frame of the heart valve prosthesis are pushedcloser and closer together to obtain the desired crossing profile. Onoccasion, during loading, the heart valve prosthesis is compressed tothe point where the frame can no longer find space along the desiredcircumference of the heart valve prosthesis and portions of the frame ofthe heart valve prosthesis will buckle, fold, or otherwise deformradially inward. When the heart valve prosthesis deforms radially inwardas described above, the frame is exposed to increased stresses that maydamage the frame and negatively affect the structural integrity of theheart valve prosthesis.

Accordingly, there is a need for heart valve prostheses that moreefficiently compress to smaller profiles without damaging the frame ofthe heart valve prosthesis.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof are directed to a modular heart valve prosthesisincluding a first heart valve device and a second heart valve device.The first heart valve device includes a first valve support including afirst prosthetic valve disposed within the valve support, and ananchoring frame surrounding the first valve support and coupled to thefirst valve support. The first prosthetic valve includes syntheticfabric leaflets having a first thickness. The second heart valve deviceincludes a second valve support including a second prosthetic valvedisposed within the second valve support. The second prosthetic valveincludes tissue leaflets having a second thickness, wherein the secondthickness is greater than the first thickness. In a first configuration,the second heart valve device is separate from the first heart valvedevice, and in a second configuration, the second heart valve device isdisposed within the first valve support of the first heart valve device.

In embodiments of the modular valve prosthesis according to any of theembodiments, the first heart valve device may be self-expanding and thesecond heart valve device may balloon expandable.

In embodiments of the modular valve prosthesis according to any of theembodiments, the first heart valve device may be self-expanding and thesecond heart valve device may self-expanding.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the synthetic fabric leaflets of the firstprosthetic valve are formed from material selected from the groupconsisting of polyester, polyethylene terephthalate (PET, e.g. DACRON),polytetrafluoroethylene (PTFE), polyurethane, cloth materials, nylonblends, and polymeric materials.

In embodiments of the modular valve prosthesis according to any of theembodiments herein the tissue leaflets of the second prosthetic valveare formed from material selected from the group consisting of bovinepericardium tissue and porcine pericardium tissue.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the first thickness is in the range of about 0.04 mmto about 0.1 mm. In embodiments of the modular valve prosthesisaccording to any of the embodiments herein, the first thickness is about0.07 mm.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the second thickness is in the range of about 0.35mm to about 0.5 mm.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the first heart valve device has a crimped diameterof approximately 27 Fr.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the second heart valve device has a crimped diameterof approximately 14 Fr.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the second heart valve device further includes askirt disposed on an outer surface of the second valve support, whereinin the second configuration, the skirt seals against an inner surface ofthe first valve support.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the first valve support and the second valve supportare both generally cylindrical.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the first valve support has an hourglass shape witha first diameter at an inflow portion thereof, a second diameter at acentral portion thereof, and a third diameter at an outflow portionthereof, wherein the first and third diameters are each larger than thesecond diameter, and wherein the second valve support has acorresponding hourglass shape.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the first valve support has a reverse hourglassshape with a first diameter at an inflow portion thereof, a seconddiameter at a central portion thereof, and a third diameter at anoutflow portion thereof, wherein the first and third diameters are eachsmaller than the second diameter, and wherein the second valve supporthas a corresponding reverse hourglass shape.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the second valve support includes a brim at aninflow end thereof, wherein the brim is parallel to a centrallongitudinal axis of the second valve support with the second heartvalve device in a radially compressed configuration, wherein the brim isdisposed radially outward at a non-zero angle with respect to thecentral longitudinal axis with the second heart valve device in aradially expanded configuration, and wherein in the second configurationof the second heart valve device, the brim is proximal of an inflow endof the first valve support. In embodiments, the non-zero angle of thebrim with the second heart valve device in the radially expandedconfiguration is between 30 and 90 degrees.

In embodiments of the modular valve prosthesis according to any of theembodiments herein, the second heart valve device further includes barbsextending radially outward from an outer surface of the second valvesupport such that with the second heart valve device in the secondconfiguration, the barbs engage the first valve support.

Embodiments hereof are also directed to a method of delivering anddeploying a modular heart valve prosthesis. The method includesdelivering a first heart valve device in a radially compressedconfiguration to a site of a native heart valve. The first heart valvedevice includes a first valve support including a first prosthetic valvecomprising synthetic fabric leaflets disposed within the valve supportand an anchoring frame surrounding the first valve support and coupledto the first valve support. The method further includes deploying thefirst heart valve device by radially expanding the first heart valvedevice such that the anchoring frame is disposed within native leafletsof the native heart valve. After deploying the first heart valve device,the method further includes delivering a second heart valve device in aradially compressed configuration to within the first valve support, thesecond heart valve device including a second valve support and a secondprosthetic valve comprising tissue leaflets disposed within the secondvalve support. The method further includes deploying the second heartvalve device by radially expanding the second valve support such thatthe second valve support engages the first prosthetic valve and thefirst valve support.

In embodiments of methods of delivering and deploying a modular heartvalve prosthesis according to any of the embodiments hereof, the step ofdeploying the first heart valve device comprises releasing the firstheart valve device from a sheath such that the first heart valve deviceself-expands.

In embodiments of methods of delivering and deploying a modular heartvalve prosthesis according to any of the embodiments hereof, the step ofdeploying the second heart valve device comprises radially expanding thesecond valve support with a balloon.

In embodiments of methods of delivering and deploying a modular heartvalve prosthesis according to any of the embodiments hereof, the firstheart valve device is disposed in a first catheter for the step ofdelivering the first heart valve device.

In embodiments of methods of delivering and deploying a modular heartvalve prosthesis according to any of the embodiments hereof, after thestep of deploying the first heart valve device from a first catheter,the first catheter is withdrawn from the site of the native heart valve.

In embodiments of methods of delivering and deploying a modular heartvalve prosthesis according to any of the embodiments hereof, after thesteps of deploying the first heart valve device from a first catheterand withdrawing the first catheter, the second heart valve delivered ina second catheter.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following description of embodiments thereof asillustrated in the accompanying drawings. The accompanying drawings,which are incorporated herein and form a part of the specification,further serve to explain the principles of the invention and to enable aperson skilled in the pertinent art to make and use the invention. Thedrawings are not to scale.

FIG. 1 depicts perspective view of a modular heart valve prosthesis inaccordance with an embodiment hereof.

FIG. 2 depicts a perspective view of a first heart valve device of themodular heart valve prosthesis of FIG. 1 according to an embodimenthereof.

FIG. 3 depicts a perspective view of a second heart valve device of themodular heart valve prosthesis of FIG. 1 according to an embodimenthereof.

FIG. 4 depicts a schematic side view of the first heart valve device ofFIG. 2 of the modular heart valve prosthesis of FIG. 1.

FIG. 5 depicts a schematic side view of the second heart valve device ofFIG. 3 of the modular heart valve prosthesis of FIG. 1.

FIG. 6 depicts a schematic side view of the modular heat valveprosthesis of FIG. 1 with the second heart valve device deployed withinthe first heart valve device.

FIG. 7 depicts a schematic side view of a first heart valve device of amodular heart valve prosthesis according to an embodiment hereof.

FIG. 8 depicts a schematic side view of a second heart valve deviceconfigured to be deployed within the first heart valve device of FIG. 7to form a modular heart valve prosthesis.

FIG. 9 depicts a schematic side view of the second heart valve device ofFIG. 8 deployed within the first heart valve device of FIG. 7 to form amodular heart valve prosthesis according to an embodiment hereof.

FIG. 10 depicts a schematic side view of a first heart valve device of amodular heart valve prosthesis according to an embodiment hereof.

FIG. 11 depicts a schematic side view of a second heart valve deviceconfigured to be deployed within the first heart valve device of FIG. 10to form a modular heart valve prosthesis.

FIG. 12 depicts a schematic side view of the second heart valve deviceof FIG. 11 deployed within the first heart valve device of FIG. 10 toform a modular heart valve prosthesis according to an embodiment hereof.

FIG. 13 depicts a schematic side view of a first heart valve device of amodular heart valve prosthesis according to an embodiment hereof.

FIG. 14 depicts a schematic side view of a second heart valve deviceconfigured to be deployed within the first heart valve device of FIG. 13to form a modular heart valve prosthesis.

FIG. 15 depicts a schematic side view of the second heart valve deviceof FIG. 14 deployed within the first heart valve device of FIG. 13 toform a modular heart valve prosthesis according to an embodiment hereof.

FIGS. 16-20 depict schematically a method for delivering and deployingof a first heart valve device side view of a first heart valve device ofa modular heart valve prosthesis according to an embodiment hereof.

FIGS. 21-24 depict schematically for delivering and deploying a secondheart valve device within the first heart valve device to form themodular heart valve prosthesis.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal”, when used in the following description to refer to a nativevessel, native valve, or a device to be implanted into a native vesselor native valve, such as a heart valve prosthesis, are with reference tothe direction of blood flow. Thus, “distal” and “distally” refer topositions in a downstream direction with respect to the direction ofblood flow and the terms “proximal” and “proximally” refer to positionsin an upstream direction with respect to the direction of blood flow.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Although the description of embodiments hereof is in thecontext of the treatment of heart valves such as the pulmonary, aortic,mitral, or tricuspid valve, the invention may also be used in any otherbody passageways where it is deemed useful. Furthermore, there is nointention to be bound by any expressed or implied theory presented inthe preceding technical field, background, brief summary or thefollowing detailed description.

FIG. 1 is a perspective view of an exemplary heart valve prosthesis 100for use in embodiments hereof. The heart prosthesis 100 is a modularheart valve prosthesis including a first heart valve device 101 and asecond heart valve device 150. As can be seen in FIG. 1, the secondheart valve device 150 is separate from the first heart valve device 101until the second heart valve device 150 is disposed within the firstheart valve device in vivo, as will be explained in more detail below.

The first heart valve device 101 as illustrated and described herein isnot limited to the specific embodiments described herein. It isunderstood that any number of alternate heart valve prostheses and/orstent assemblies can be used with the invention described herein. Thefirst heart valve device is merely exemplary and is similar to heartvalve prostheses described in more detail in U.S. Pat. No. 9,034,032,WIPO Publication No. WO 2014/144937, and WIPO Publication No. WO2013/059747, each of which is herein incorporated by reference in itsentirety. Other non-limiting examples of transcatheter heart valveprostheses that may be used as the first heart valve device describedherein are described in U.S. Patent Application Publication No.2012/0101572, U.S. Patent Application Publication No. 2012/0035722, U.S.Patent Application Publication No. 2006/0265056, U.S. Patent ApplicationPublication No. 2007/0239266, and U.S. Patent Application PublicationNo. 2007/0239269, each of which is incorporated by reference herein inits entirety.

As shown in FIGS. 1, 2 and 4, the first heart valve device 101 includesan anchoring member or frame 102 at least partially surrounding andcoupled to a valve frame or support 104. The first heart valve device101 further includes a first or temporary prosthetic valve 106 coupledto, mounted within, or otherwise carried by the valve support 104. Thefirst heart valve device 101 is configured for placement within a nativemitral valve and includes a downstream or distal end portion, referredto herein as an outflow portion 108, and an upstream or proximal endportion, referred to herein as an inflow portion 110. The first heartvalve device 101 may also include tissue engaging elements 114. Forexample, the tissue engaging elements 114 may be spikes or barbsdisposed on an outer wall or surface of the anchoring frame 102 andextending in an upward and/or radially outward direction to engage, andin some embodiments, penetrate the native tissue to facilitate retentionor maintain position of the device in a desired implanted location.

The anchoring frame 102 is a generally tubular component or stent. Inthe embodiment shown in FIGS. 1-2, the anchoring frame 102 has afunnel-like or hyperboloid shape or profile. Further, the anchoringframe 102 includes openings 116 that may be diamond-shaped. Theanchoring frame 102 may be formed by a laser-cut manufacturing methodand/or another conventional frame forming methods. For example, theanchoring frame 102 may be laser cut from a single metal tube into thedesired geometry, creating a tubular scaffold of interconnected struts124A that form the openings 116. The anchoring frame 102 may then beshaped into a desired configuration, e.g. funnel-like or hyperboloidshape, using known shape-setting techniques for such materials. It willbe understood the anchoring frame 102 may have other shapes andconfigurations. For example, in another embodiment, the anchoring frame102 may include a plurality of posts connected circumferentially by aplurality of struts as described herein with respect to the valvesupport 104.

The first heart valve device 101 may further include a brim 118. Thebrim 118 is disposed at the inflow portion 110 of the first heart valvedevice 101 and is attached to and extends from an inflow end 103 of theanchoring frame 102. The brim 118 is a flared lip or ridge of theanchoring frame 102 that extends at least partially radially outwardrelative to the anchoring frame 102. The brim 118 may be disposed at anangle relative to the outer wall or surface of the anchoring frame 102,for example, between 30 and 90 degrees, or between 40 and 50 degrees. Inthe embodiment shown in FIGS. 1-2, the brim 118 includes two sinusoidalrings 120A, 120B and a sealing component 128 disposed over or coveringat least a downstream surface of the sinusoidal rings 120A, 120B. Thesinusoidal rings 120A, 120B are disposed out of phase relative to eachother, and may be woven together or may be disposed in an overlappingmanner and coupled together. The sealing component 128 may be formedfrom a suitable natural or biological material such as pericardium oranother membranous tissue including, but not limited to intestinalsubmucosa. Alternatively, the sealing component 128 may be alow-porosity woven fabric, such as polyester, polyethylene terephthalate(PET), or polytetrafluoroethylene (PTFE), or may be a knit or wovenpolyester, such as a polyester or PTFE knit.

The valve support 104 may be a generally tubular component or stent thatsupports the temporary prosthetic valve 106 within the interior of thevalve support 104. In some embodiments, the valve support 104 includes aplurality of posts 122 connected circumferentially by a plurality ofstruts 124B. The plurality of posts 122 and the plurality of struts 124Bmay be arranged in a variety of geometrical patterns that expand andprovide sufficient resilience and column strength for maintaining theintegrity of the temporary prosthetic valve 106. Generally, theplurality of posts 122 extend along an axial direction generallyparallel to the central longitudinal axis of the first heart valvedevice 100. Further, the plurality of posts 122 extend axially orlongitudinally across multiple rows of the plurality of struts 124B toprovide column strength to the valve support 104. The plurality ofstruts 124B extend circumferentially around and transverse to thelongitudinal axis LA1. As will be understood, the valve support 104 mayhave other shapes and configurations. For example, in anotherembodiment, the valve support 104 may be laser cut from a single metaltube into the desired geometry, creating a tubular scaffold ofinterconnected struts.

In embodiments hereof, both the anchoring frame 102 and the valvesupport 104 are self-expanding to return to a radially expanded statefrom a radially compressed state and may be made from materials such as,but not limited to stainless steel, a pseudo-elastic metal such as anickel titanium alloy (e.g. NITINOL), or a so-called super alloy, whichmay have a base metal of nickel, cobalt, chromium, or other metal.“Self-expanding” as used herein means that a structure/component has amechanical memory to return to the radially expanded configuration orstate as described herein. Thus, the first heart valve device 101 has aradially compressed configuration for delivery within a delivery systemand the radially expanded configuration for deployment within an annulusof the native heart valve site.

As previously described, the first heart valve device 100 includes thetemporary prosthetic valve 106 within the interior of the valve support104. In an embodiment hereof, the temporary prosthetic valve 106 ispositioned adjacent to an inflow end 105 of the valve support 104. Thetemporary prosthetic valve 106 is configured as a one-way valve to allowblood flow in one direction and thereby regulate blood flowtherethrough. The temporary prosthetic valve 106 is capable of blockingflow in one direction to regulate flow therethrough via valve leaflets107 that may form a bicuspid or tricuspid replacement valve. Thetemporary prosthetic valve 106 is referred to as a temporary valvebecause the valve leaflets are made of relatively thin material suchthat the first heart valve device 101 may be radially compressed to asmaller diameter or profile radially compressed configuration fordelivery. Such a smaller diameter or profile is particularly useful formitral valve prostheses because a transseptal approach to the nativemitral valve requires a tight turning radius. A larger mitral valveprosthesis may have difficulty making the required turn in the radiallycompressed configuration. Thus, the valve leaflets 107 of the temporaryprosthetic valve 106 may be made of thin synthetic materials such as,but not limited to, polyester, polyethylene terephthalate (PET),polytetrafluoroethylene (PTFE), polyurethane, cloth materials, nylonblends, and polymeric materials. In a particular example, the valveleaflets 107 are formed of polyethylene terephthalate (PET) fabric. Thevalve leaflets 107 have a thickness in the range of about 0.04 mm toabout 0.10 mm. In an embodiment, the valve leaflets 107 have a thicknessof approximately 0.07 mm. The valve leaflets 107 are sutured orotherwise securely and sealingly attached to an inner circumference ofthe valve support 104 and/or a graft material 112 which encloses orlines the valve support 104. The terms “approximately” and “about” asused herein are used to encompass ranges and sizes within 10% of thesizes listed.

The first heart valve device 101 may also include one or more layers ofthe graft material 112. The graft material 112 may be coupled to theanchoring frame 102 and/or to the valve support 104 to preventparavalvular leaks between the first heart valve device 101 and thenative tissue and/or between the anchoring frame 102 and the valvesupport 104. The graft material 112 is formed from a suitable natural orbiological graft material such as pericardium or another membranoustissue including, but not limited to intestinal submucosa.Alternatively, the graft material 112 may be a low-porosity wovenfabric, such as polyester, polyethylene terephthalate (PET), orpolytetrafluoroethylene (PTFE), which creates a one-way fluid passagewhen attached to the frame. In one embodiment, the graft material 112may be a knit or woven polyester, such as a polyester or PTFE knit,which can be utilized when it is desired to provide a medium for tissueingrowth and the ability for the fabric to stretch to conform to acurved surface. Polyester velour fabrics may alternatively be used, suchas when it is desired to provide a medium for tissue ingrowth on oneside and a smooth surface on the other side. In the embodiment of FIGS.1-2, the first heart valve device 101 includes two layers of the graftmaterial 112. More precisely, a first layer 112A is coupled to theanchoring frame 102 and extends around an inner wall or surface of theanchoring frame 102 while a second layer 112B is coupled to the valvesupport 104 and extends around an inner wall or surface of the valvesupport 104. However, this is by way of example and not limitation. Inother embodiments, the first heart valve device 101 can have a greateror lesser number of layers of graft material. For example, the graftmaterial 112 may be coupled to an inner and/or an outer surface ofeither the anchoring frame 102 and/or the valve support 104 in anycombination.

As noted above, it is desirable for the first heart valve device 101 tohave a small diameter or profile when in the radially compressedconfiguration. Therefore, as described above, the first heart valvedevice 101 includes a thin prosthetic valve 106 disposed within thevalve support 104, approximately 0.07 mm in thickness. A first heartvalve device 101 of the design described above with the prosthetic valve106 having a 0.07 mm thickness can be radially compressed toapproximately 27 Fr outer diameter. However, such a thin prostheticvalve 106 cannot serve as a long-term replacement valve for the nativemitral valve due to limited durability of such a thin fabric prostheticvalve. However, the prosthetic valve 106 can serve as a temporary orshort term valve.

Thus, as described in more detail below, the first heart valve device101 with the temporary prosthetic valve 106 is delivered and deployed atthe native mitral valve. The second heart valve device 150, as shown inFIGS. 1 and 3, is thereafter delivered and deployed within the valvesupport 104 of the first heart valve device 101 to form the heart valveprosthesis 100. The second heart valve device 150 is thus separate fromthe first heart valve device 101 until the second heart valve device 150is delivered to and deployed within the already deployed first heartvalve device 101.

The second heart valve device 150 may be generally tubular. The secondheart valve device 150 includes a valve support or frame 152 and asecond or permanent prosthetic valve 154 disposed within and coupled tothe frame 152. The second heart valve device 150 includes an inflow end158 and an outflow end 160. The second heart valve device 150 mayfurther include a skirt 156 coupled to the valve support 152.

The valve support 152 may be a generally tubular component or stent thatsupports the prosthetic valve 154 within the interior of the valvesupport 152. The valve support 152 is preferably balloon or mechanicallyexpandable for improved interaction with the valve support 104 of thefirst heart valve device 101. In other words, the valve support 152 ismade from a material that is plastically deformable such that the valvesupport requires mechanical or balloon expansion and that upon suchexpansion, the valve support 152 maintains the expanded configuration.However, this is not meant to be limiting, and the valve support 152 mayinstead be self-expanding. As described in further detail below, thecylindrical shape of both the valve support 104 of the first heart valvedevice 101 and the valve support 152 of the second heart valve device150 may not provide sufficient support for the second heart valve device150 if the second heart valve device is self-expanding. However,features described below may be included in the second heart valvedevice 150 to ensure proper engagement between the valve support 104 ofthe first heart valve device 101 and the valve support 152 of the secondheart valve device 150. For example, and not by way of limitation,over-sizing of the valve support 152, barbs added to the second heartvalve device 150, and/or a brim added to the second heart valve device150, all described in further detail below, may be utilized. The valvesupport 152 may be formed of stainless steel or other suitable metals,such as platinum iridium, cobalt chromium alloys such as MP35N, orvarious types of polymers or other materials known to those skilled inthe art, including said materials coated with various surface depositsto improve clinical functionality.

In some embodiments, the valve support 152, when expanded, a diameter ofthe inflow end 158 of the valve support 152 can be the same as adiameter of the outflow end 160 of the valve support 152. The valvesupport 152 can be formed by a laser-cut manufacturing method and/oranother conventional stent forming method as would be understood by oneof ordinary skill in the art. The cross-section of the valve support 152can be circular, ellipsoidal, rectangular, hexagonal, square, or otherpolygonal shape. It is preferable that the cross-sectional shape of thevalve support 152 matches the cross-sectional shape of the valve support104, and that such a shape be circular.

In an embodiment, the valve support 152 may be formed with a pluralityof struts 180 and a plurality of bends or crowns 178 being formedbetween adjacent pairs struts 180. The struts 180 and the crowns 178 maybe formed into multiple rows of struts and crowns. In embodiments, anode is formed between crowns of adjacent rows. In the embodiment shown,there are seven rows of struts 180 and crowns 178, but this is not meantto be limiting, and there can more or fewer rows. The struts 180 andcrowns 178 of adjacent rows side openings 182. In the embodiment shown,the inflow end 158 of the valve support 152 includes twelve crowns 178,but this is not meant to be limiting, and the valve support 152 caninclude more of fewer crowns 178A at the inflow end 158. In anembodiment, the outflow end 160 of the valve support 152 may alsoinclude twelve endmost outflow crowns 178A. In other embodiments, theoutflow portion 164 may include fewer or more endmost outflow crowns178, for example, six endmost outflow crowns 178A.

The description above of the valve support 152 is merely exemplary andnot meant to be limiting. In particular, the specific structure ofstruts, crowns, and axial frame members is not meant to be limiting. Inother examples, the valve support 152 of the second valve device 150 maybe similar in structure to the valve support 104 of the first heartvalve device 101, except that it is mechanically or balloon expandable,as described above.

The second or permanent prosthetic valve 154 is disposed within andsecured to the valve support 152. The prosthetic valve 154 is configuredas a one-way valve to allow blood flow in one direction and therebyregulate blood flow therethrough. The prosthetic valve 154 is capable ofblocking flow in one direction to regulate flow therethrough via valveleaflets 155 that may form a bicuspid or tricuspid replacement valve.

As noted above, the second or permanent prosthetic valve 154 is intendedto function within the native valve as a replacement valve for anextended period of time. By “permanent”, as used herein, it is notintended that the second prosthetic valve 154 last forever. Instead, itis meant to last the typical life of a prosthetic replacement valve foruse in human hearts. Thus, the valve leaflets 155 of the prostheticvalve 154 are made of more durable, and thicker material than the valveleaflets 107 of the temporary prosthetic 106 described above. Forexample, the valve leaflets 107 of the prosthetic valve 154 may be ofbiologic tissue such as pericardial tissue or xenograft valve tissuesuch as bovine pericardium or porcine pericardium. The valve leaflets155 of the prosthetic valve 154 have a thickness in the range of about0.35 mm to about 0.50 mm. In a particular, example, the valve leaflets155 are bovine pericardium tissue approximately 0.4 mm in thickness.

As noted above, the second heart valve device 150 may also include askirt 156 coupled to the valve support 152. The skirt 156 may be one ormore layers of a graft material. The graft material of the skirt 156 maybe coupled to the valve support 152 to provide a more secure engagementbetween the second heart valve device 150 and the valve support 104 ofthe first heart valve device 101, and to prevent paravalvular leaksbetween the second heart valve device 150 and valve support 104 of thefirst heart valve device 101. The skirt 156 may be formed from asuitable natural or biological graft material such as pericardium oranother membranous tissue including, but not limited to intestinalsubmucosa. Alternatively, the skirt 156 may be a low-porosity wovenfabric, such as polyester, polyethylene terephthalate (PET), orpolytetrafluoroethylene (PTFE), which creates a one-way fluid passagewhen attached to the frame. In the embodiment of FIGS. 1 and 3, theskirt 156 of the second heart valve device 150 includes two layers ofgraft material. More precisely, a first layer is coupled to the innersurface of the valve support 152 and a second layer is coupled to theouter surface of the valve support 152. However, this is by way ofexample and not limitation. In other embodiments, the skirt 156 may havea single layer, more than two layers, or may be excluded.

FIGS. 7-9 schematically depict a modular heart valve prosthesis 200according to another embodiment hereof. Similar to the modular heartvalve prosthesis 100, the modular heart valve prosthesis 200 includes afirst heart valve device 201 and a second heart valve device 250configured to be deployed within the first heart valve device 201, asshown in FIG. 9.

As shown in FIGS. 7 and 9, the first heart valve device 201 of themodular heart valve prosthesis 200 includes an anchoring member or frame102 at least partially surrounding and coupled to a valve frame orsupport 204. The first heart valve device 201 further includes a firstor temporary prosthetic valve 206 coupled to, mounted within, orotherwise carried by the valve support 204. The first heart valve device201 is configured for placement within a native mitral valve andincludes a downstream or distal end portion, referred to herein as anoutflow portion 208, and an upstream or proximal end portion, referredto herein as an inflow portion 210.

The anchoring member 102 of the first heart valve device 201 is numberedthe same as the anchoring member 102 of the first heart valve device of101 of the modular heart valve prosthesis 100 because it issubstantially the same as the anchoring member 102 of the first heartvalve device 101. Therefore, the detailed description thereof will notbe repeated for the modular heart valve prosthesis 200, and all details,descriptions, variations, and additional items described with respect tothe anchoring member 102 of the modular heart valve prosthesis 100 (suchas, but not limited to the brim 118, tissue engaging elements 114, graftmaterial 112, sealing component 128, etc.) may be included andincorporated in the anchoring member 102 of the modular heart valveprosthesis 200.

The valve support 204 of the first heart valve device 201 of the modularheart valve prosthesis 200 may be a generally tubular component or stentthat supports a temporary prosthetic valve 206 within the interior ofthe valve support 204. In some embodiments, the valve support 204 may beany structure of a stent, including longitudinal posts, circumferentialstruts and crowns, and other structural features known to those skilledin the art. The valve support 204 may be similar in structure to thevalve support 104, except for the shape thereof. In particular, as canbe seen in FIG. 4, the valve support 104 is generally cylindrical,whereas, as can be seen in FIG. 7, the valve support 204 is generallyhourglass in shape. In particular, the valve support 204 includes afirst diameter D_(i) at an inflow end thereof, a second diameter D_(c)in a central portion thereof, and a third diameter D_(o) at an outflowend thereof, wherein the first and third diameters D_(i) and D_(o) arelarger than the second diameter D_(c). In embodiments hereof, both theanchoring frame 102 and the valve support 204 of the first heart valvedevice 201 are self-expanding to return to a radially expanded statefrom a radially compressed state and may be made from materials such as,but not limited to stainless steel, a pseudo-elastic metal such as anickel titanium alloy (e.g. NITINOL), or a so-called super alloy, whichmay have a base metal of nickel, cobalt, chromium, or other metal.“Self-expanding” as used herein means that a structure/component has amechanical memory to return to the radially expanded configuration orstate as described herein. Thus, the first heart valve device 201 has aradially compressed configuration for delivery within a delivery systemand the radially expanded configuration for deployment within an annulusof the native heart valve site.

As previously described, the first heart valve device 201 includes thetemporary prosthetic valve 206 within the interior of the valve support204. The temporary prosthetic valve 206 is configured as a one-way valveto allow blood flow in one direction and thereby regulate blood flowtherethrough. The temporary prosthetic valve 206 is capable of blockingflow in one direction to regulate flow therethrough via valve leaflets207 that may form a bicuspid or tricuspid replacement valve. Thetemporary prosthetic valve 206 is referred to as a temporary valvebecause the valve leaflets are made of relatively thin material suchthat the first heart valve device 201 may be radially compressed to asmaller diameter or profile radially compressed configuration fordelivery. Such a smaller diameter or profile is particularly useful formitral valve prostheses because a transseptal approach to the nativemitral valve requires a tight turning radius. A larger mitral valveprosthesis may have difficulty making the required turn in the radiallycompressed configuration. Thus, the valve leaflets 207 of the temporaryprosthetic valve 106 may be made of thin synthetic materials such as,but not limited to, polyester, polyethylene terephthalate (PET),polytetrafluoroethylene (PTFE), polyurethane, cloth materials, nylonblends, and polymeric materials. In a particular example, the valveleaflets 107 are formed of polyethylene terephthalate (PET) fabric. Thevalve leaflets 107 have a thickness in the range of about 0.04 mm toabout 0.10 mm. In an embodiment, the valve leaflets 107 have a thicknessof approximately 0.07 mm. The valve leaflets 207 are sutured orotherwise securely and sealingly attached to an inner circumference ofthe valve support 204 and/or a graft material (not shown) which enclosesor lines the valve support 204.

As noted above, it is desirable for the first heart valve device 201 tohave a small diameter or profile when in the radially compressedconfiguration. Therefore, as described above, the first heart valvedevice 201 includes a thin prosthetic valve 206 disposed within thevalve support 204, approximately 0.07 mm in thickness. However, such athin prosthetic valve 206 cannot serve as a long-term replacement valvefor the native mitral valve due to limited durability of such a thinfabric prosthetic valve. However, the prosthetic valve 206 can serve asa temporary or short term valve.

Thus, as described in more detail below, the first heart valve device201 with the temporary prosthetic valve 206 is delivered and deployed atthe native mitral valve. The second heart valve device 250, as shown inFIGS. 8 and 9, is thereafter delivered and deployed within the valvesupport 204 of the first heart valve device 201 to form the modularheart valve prosthesis 200. The second heart valve device 250 is thusseparate from the first heart valve device 201 until the second heartvalve device 250 is delivered to and deployed within the alreadydeployed first heart valve device 201.

The second heart valve device 250 may be generally tubular. The secondheart valve device 250 includes a valve support or frame 252 and asecond or permanent prosthetic valve 254 disposed within and coupled tothe frame 252. The second heart valve device 250 includes an inflow end258 and an outflow end 260. The second heart valve device 250 mayfurther include a skirt (not shown) coupled to the valve support 252.

The valve support 252 may be a stent or frame that supports theprosthetic valve 254 within the interior of the valve support 252. Thevalve support 252 may be any stent structure including components suchas, but not limited to, struts, bends/crowns, longitudinal bars, andother structural features known to those skilled in the art. The valvesupport 252 of the second valve device 250 may be similar to the valvesupport 152 of the embodiment of FIGS. 1-6 except that the valve support152 is generally cylindrical, as shown in FIG. 5, and the valve support252 has a hourglass shape, as shown in FIGS. 8 and 9. Thus, the valvesupport 252 includes a first diameter D_(2i) at the inflow end thereof,and second diameter D_(2c) at a central portion thereof, and the thirddiameter D_(2o) at the outflow end thereof, the first and thirddiameters D_(2i), D_(2o) being larger than the second diameter D_(2c).

Thus, the valve support 252 of the second valve device 250 has a similarhourglass shape as the valve support 204 of the first heart valve device201. The hourglass shape of each valve support 204/252 enables a moresecure connection between the valve support 252 and the valve support204 when the valve support 252 is deployed within the valve support 204,as shown in FIG. 9. The corresponding hourglass shapes enable the use ofa self-expanding valve support 252 with less of a likelihood of thevalve support 252 of the second heart valve device 250 moving ormigrating after deployment within the valve support 204 than if thevalve supports were cylindrical.

To further enhance the engagement between the valve support 252 and thevalve support 204 when both are self-expanding, the valve support 252 ofthe second heart valve device 250 may be oversized with respect to thevalve support 204 of the first heart valve device 201. In other words,with self-expanding supports or frames, the support is configured toexpand to a pre-set diameter when released from an outside constraint,such as a sheath. In the present situation, the valve support 204 of thefirst heart valve device 201 expands to its pre-set diameter, forexample and not by way of limitation, 23 mm for the second diameterD_(c). The valve support 252 of the second heart valve device 250 may beoversized in its pre-set expanded diameter such that its pre-setexpanded diameter without any outside constraints is, for example andnot by way of limitation, 27 mm for its second diameter D_(2c). Thus, asdescribed in more detail below, with the first heart valve device 201deployed such that the valve support 204 radially expanded to itsunconstrained diameter, the second heart valve device 250 is deployedwithin the valve support 204, such as by releasing the second heartvalve device 250 to allow the valve support 252 of the second heartvalve device 250 self-expand. Thus, the valve support 252 attempts toexpand to its unconstrained diameter of, for example, 27 mm. However,when the valve support 252 reaches the diameter of 23 mm, the valvesupport 252 contacts the valve support 204. Being self-expanding, thevalve support 252 continues to attempt to radially expand against aradially inward force of the valve support 204 which is pre-set to asmaller diameter, for example, 23 mm, as explained above. The radiallyoutward force of the valve support 252 attempting to self-expand againstthe opposing radially inward force of the valve support 204 remaining atits pre-set diameter creates opposing forces, as depicted by the arrowsin FIG. 9, that tend to keep the valve support 252 engaged with thevalve support 204, thereby minimizing the risk of migration of the valvesupport 252. Although the oversizing discussed above, specificallymentions the second diameters D_(c) and D_(2c) of the valve support 204and the valve support 252, those skilled in the art would recognize thatthis is merely an example and not a limitation. In embodiments, theunconstrained diameters along the length of the valve support 252 may beoversized as compared corresponding unconstrained diameters of the valvesupport 204. In other embodiments only the unconstrained diameters ofsome portions of the valve support 252 may be oversized as compared tothe unconstrained diameters of corresponding portions of the valvesupport 204. For example, and not by way of limitation, in someembodiments, the first and third diameter D_(2i), D_(2o) of the valvesupport 252 may be oversized as compared to the first and thirddiameters D_(i), D_(o) of the valve support 204. In other embodiments,only the second diameter D_(2c) of the valve support 252 may beoversized as compared to the second diameter D_(c) of the valve support204. Any combination of oversizing may be utilized.

Similar to the second heart valve device 150 of the embodiment of FIGS.1-6, the second heart valve device 250 of the embodiment of FIGS. 7-9may include a skirt (not shown) coupled to the valve support 252. Theskirt may be one or more layers of a graft material. The graft materialof the skirt may be coupled to the valve support 252 to provide a moresecure engagement between the second heart valve device 250 and thevalve support 204 of the first heart valve device 201, and to preventparavalvular leaks between the second heart valve device 250 and valvesupport 204 of the first heart valve device 201. The skirt may be formedfrom a suitable natural or biological graft material such as pericardiumor another membranous tissue including, but not limited to intestinalsubmucosa. Alternatively, the skirt may be a low-porosity woven fabric,such as polyester, polyethylene terephthalate (PET), orpolytetrafluoroethylene (PTFE), which creates a one-way fluid passagewhen attached to the frame.

FIGS. 10-12 schematically depict a modular heart valve prosthesis 300according to another embodiment hereof. Similar to the modular heartvalve prostheses 100 and 200, the modular heart valve prosthesis 300includes a first heart valve device 301 and a second heart valve device350 configured to be deployed within the first heart valve device 301,as shown in FIG. 12.

As shown in FIGS. 10 and 12, the first heart valve device 301 of themodular heart valve prosthesis 300 includes an anchoring member or frame102 at least partially surrounding and coupled to a valve frame orsupport 304. The first heart valve device 301 further includes a firstor temporary prosthetic valve 306 coupled to, mounted within, orotherwise carried by the valve support 304. The first heart valve device301 is configured for placement within a native mitral valve andincludes a downstream or distal end portion, referred to herein as anoutflow portion 308, and an upstream or proximal end portion, referredto herein as an inflow portion 310.

The first heart valve device 301 identical to the first heart valvedevice 201 of FIG. 7-9, and thus need not be described in detail here.All of the description and variations noted above with respect to thefirst heart valve device 201 of FIG. 7-9, which includes the descriptionand variations described with respect to the first heart valve device101 of FIGS. 1-6, and in particular with respect to the anchoring member102 of the first heart valve device 101, are incorporated into thedescription of the first heart valve device 301 of FIGS. 10 and 12.Thus, for example, and not by way of limitation, the anchoring member102 of the first heart valve device 301 may include all of the details,descriptions, variations, and additional items described with respect tothe anchoring member 102 of the modular heart valve prostheses 100, 200(such as, but not limited to the brim 118, tissue engaging elements 114,graft material 112, sealing component 128, etc.). Further, all detailsof the valve support 204 described with respect to the first heart valvedevice 201 of FIGS. 7-9 are incorporated into the valve support 304 ofthe first heart valve device 301 of FIGS. 10-12. Thus, the valve support304 is a generally hourglass shape with a first diameter D_(i) at aninflow end thereof, a second diameter D_(c) in a central portionthereof, and a third diameter D_(o) at an outflow end thereof, whereinthe first and third diameters D_(i) and D_(o) are larger than the seconddiameter D_(c). The first heart valve device 301 further includes atemporary prosthetic valve 306 disposed within the interior of the valvesupport 304. The prosthetic valve 306 is as described above with respectto the prosthetic valves 106 and 206. Therefore, the details of thetemporary prosthetic valve 306 will not be repeated.

In embodiments hereof, both the anchoring frame 102 and the valvesupport 304 of the first heart valve device 301 are self-expanding toreturn to a radially expanded state from a radially compressed state andmay be made from materials such as, but not limited to stainless steel,a pseudo-elastic metal such as a nickel titanium alloy (e.g. NITINOL),or a so-called super alloy, which may have a base metal of nickel,cobalt, chromium, or other metal. “Self-expanding” as used herein meansthat a structure/component has a mechanical memory to return to theradially expanded configuration or state as described herein. Thus, thefirst heart valve device 301 has a radially compressed configuration fordelivery within a delivery system and the radially expandedconfiguration for deployment within an annulus of the native heart valvesite.

As previously described, the prosthetic valve 306 of the first heartvalve device 301 is referred to as a temporary valve because the valveleaflets thereof are made of relatively thin material such that thefirst heart valve device 301 may be radially compressed to a smallerdiameter or profile radially compressed configuration for delivery. Sucha smaller diameter or profile is particularly useful for mitral valveprostheses because a transseptal approach to the native mitral valverequires a tight turning radius. A larger mitral valve prosthesis mayhave difficulty making the required turn in the radially compressedconfiguration. Thus, the valve leaflets of the temporary prostheticvalve 206 may be made of thin synthetic materials such as, but notlimited to, polyester, polyethylene terephthalate (PET),polytetrafluoroethylene (PTFE), polyurethane, cloth materials, nylonblends, and polymeric materials. In a particular example, the valveleaflets 107 are formed of polyethylene terephthalate (PET) fabric. Thevalve leaflets have a thickness in the range of about 0.04 mm to about0.10 mm. In an embodiment, the valve leaflets 107 have a thickness ofapproximately 0.07 mm. The valve leaflets are sutured or otherwisesecurely and sealingly attached to an inner circumference of the valvesupport 304 and/or a graft material (not shown) which encloses or linesthe valve support 304.

As explained above, it is desirable for the first heart valve device 301to have a small diameter or profile when in the radially compressedconfiguration. Therefore, as described above, the first heart valvedevice 301 includes a thin prosthetic valve 306 disposed within thevalve support 304, approximately 0.07 mm in thickness. However, such athin prosthetic valve 306 cannot serve as a long-term replacement valvefor the native mitral valve due to limited durability of such a thinfabric prosthetic valve. However, the prosthetic valve 306 can serve asa temporary or short term valve.

Thus, as described in more detail below, the first heart valve device301 with the temporary prosthetic valve 306 is delivered and deployed atthe native mitral valve. The second heart valve device 350, as shown inFIGS. 11 and 12, is thereafter delivered and deployed within the valvesupport 304 of the first heart valve device 301 to form the modularheart valve prosthesis 300. The second heart valve device 350 is thusseparate from the first heart valve device 301 until the second heartvalve device 350 is delivered to and deployed within the alreadydeployed first heart valve device 301.

The second heart valve device 350 shown in FIGS. 11 and 12 is identicalto the second heart valve device 250 shown in FIGS. 8 and 9, except foradditional features described below. Therefore, all of the details ofthe second heart valve device 250 are incorporated into the second heartvalve device 350 and will not be repeated with respect to the secondheart valve device 350. Therefore, for example and not by way oflimitation, the second heart valve device 350 includes a valve support352 and a second or permanent prosthetic valve 354 disposed within andcoupled to the frame 352. The second heart valve device 350 alsoincludes an inflow end 358 and an outflow end 360. The second heartvalve device 350 may further include a skirt (not shown) coupled to thevalve support 352.

The valve support 352 may be a stent or frame that supports theprosthetic valve 354 within the interior of the valve support 352. Asdescribed above with respect to the valve support 252, the valve support352 may be any stent structure including components such as, but notlimited to, struts, bends/crowns, longitudinal bars, and otherstructural features known to those skilled in the art. The valve support352 of the second valve device 350 may be similar to the valve support152 of the embodiment of FIGS. 1-6 except that the valve support 152 isgenerally cylindrical, as shown in FIG. 5, and the valve support 352 hasa hourglass shape, as shown in FIGS. 11 and 12. Thus, as describedabove, the valve support 352 includes a first diameter D_(2i) at theinflow end thereof, a second diameter D_(2c) at a central portionthereof, and the third diameter D_(2o) at the outflow end thereof, thefirst and third diameters D_(2i), D_(2o) being larger than the seconddiameter D_(2c).

Thus, the valve support 352 of the second valve device 350 has a similarhourglass shape as the valve support 304 of the first heart valve device301. The hourglass shape of each valve support 304/352 enables a moresecure connection between the valve support 352 and the valve support304 when the valve support 352 is deployed within the valve support 204,as shown in FIG. 12. The corresponding hourglass shapes enables the useof a self-expanding valve support 352 with less of a likelihood of thevalve support 352 of the second heart valve device 350 moving ormigrating after deployment within the valve support 304 than if thevalve supports were cylindrical. Further, the valve support 352 of thesecond valve device 350 may be oversized with respect to the valvesupport 304 of the first valve device 301, as described above withrespect to the valve support 252 and the valve support 204.

The second heart valve device 350 differs from the second heart valvedevice 250 in that the second heart valve device 350 includes a brim 390extending radially outwardly from the inflow end 358 of the valvesupport 352 and barbs 392 extending radially outward from an outersurface of the valve support 352. Both the brim 390 and the barbs 392enhance engagement between the second heart valve device 350 and thevalve support 304 of the first heart valve device 301. Although thesecond heart valve device 350 of FIGS. 11 and 12 includes both the brim390 and the barbs 392, it is not required that both are included.Therefore, the second heart valve device 350 can include the brim 390and not the barbs 392, the barbs 392 and not the brim 390, both the brim390 and the barbs 392, or neither the brim 390 not the barbs 392 (inwhich case the second heart valve device 350 would be like the secondheart valve device 250. Further, one of or both of the brim and thebarbs described with respect to the second heart valve device 350 may beincluded in the second heart valve devices 150, 250, and 450.

The brim 390 extends radially outwardly from an inflow end of the valvesupport 352 when in a radially expanded configuration. The brim 390 maybe a sinusoidal ring, such as one of the sinusoidal rings 120A, 120B ofthe anchoring member 102, or may be a pair of sinusoidal rings such asthe sinusoidal rings 120A, 120B of the anchoring member. In otherembodiments, the brim 390 may be a lattice of struts, or other structureformed of the same or similar material as the valve support 352. Inembodiments, the brim 390 extends parallel to a central longitudinalaxis of the valve support 352 when in a radially compressedconfiguration for delivery, and then extends radially outwardly at a 30to 90 degree angle relative to the central longitudinal axis of thevalve support 352 in a radially expanded or deployed configuration, asshown in FIGS. 11 and 12. When the second heart valve device 350 isdeployed within the valve support 304 of the first heart valve device301, as shown in FIG. 12, the brim 390 is disposed upstream of andextends radially outward of the upstream end of the valve support 304.In this manner, blood flow and other forces pushing the second heartvalve device 350 in a downstream direction are opposed by the brim 390contacting the upstream end of the valve support 304, thereby preventingdownstream migration of the second heart valve device 350. Further, thebrim 390 acts as a partial roof to the trough formed between an innersurface of the anchoring member 102 and an outer surface of the valvesupport 304, thereby reducing washout of blood from the trough.Encouraging stagnant blood in the trough accelerates filling of thetrough, which stabilizes the assembled modular valve prosthesis 300.

The barbs 392 be struts that extend radially outward from an outersurface of the valve support 352. In the embodiment shown, there arethree rows of barbs 392, however, more or fewer rows of barbs 392 may beincluded. Further the barbs 392 may be distributed around an outercircumference of the valve support 352, either equally spaced around thecircumference or asymmetrically distributed around the circumference. Inother embodiments, the barbs 390 may be distributed around only aportion of the circumference of the valve support 352. A first end ofeach barb 392 is coupled to the valve support and a second end of eachbarb 392 is a free end. The free end of each barb 392 may include asharp tip. The barbs 392 may be separate items attached to the valvesupport 352 or may be formed unitarily with the valve support 352. Inembodiments, the barbs 392 are parallel to the central longitudinal axisof the valve support 352 when in a radially compressed configuration andextend radially outward and in an upstream direction in a radiallyexpanded configuration at an angle of 15 to 75 degrees from the centrallongitudinal axis, as shown in FIGS. 11 and 12. When the second heartvalve device 350 is deployed within the valve support 304 of the firstheart valve device 301, as shown in FIG. 12, the barbs 392 of the secondheart valve device 350 engage the valve support 304, and depending onthe location of the barbs 392 relative to the valve support 304, mayextend through the temporary prosthetic valve 306 of the valve support304 and any graft material covering the valve support 304. Inembodiments, due to the barbs 392 being angled in the upstream directionand engaged with the valve support 304, forces acting on the secondheart valve device 350 in an upstream direction are opposed by thebarbs' 392 engagement with the valve support 304, thereby minimizingmigration in the upstream direction. The barbs 392 may be made of thesame or similar material as the valve support 352.

FIGS. 13-15 schematically depict a modular heart valve prosthesis 400according to another embodiment hereof. Similar to the modular heartvalve prostheses 100, 200, and 300, the modular heart valve prosthesis400 includes a first heart valve device 401 and a second heart valvedevice 450 configured to be deployed within the first heart valve device401, as shown in FIG. 15.

As shown in FIGS. 13 and 15, the first heart valve device 401 of themodular heart valve prosthesis 400 includes an anchoring member or frame102 at least partially surrounding and coupled to a valve frame orsupport 404. The first heart valve device 401 further includes a firstor temporary prosthetic valve 406 coupled to, mounted within, orotherwise carried by the valve support 404. The first heart valve device401 is configured for placement within a native mitral valve andincludes a downstream or distal end portion, referred to herein as anoutflow portion 408, and an upstream or proximal end portion, referredto herein as an inflow portion 410.

The anchoring member 102 of the first heart valve device 401 is numberedthe same as the anchoring member 102 of the first heart valve device of101 of the modular heart valve prosthesis 100 because it issubstantially the same as the anchoring member 102 of the first heartvalve device 101. Therefore, the detailed description thereof will notbe repeated for the first heart valve device 401 of the modular heartvalve prosthesis 400, and all details, descriptions, variations, andadditional items described with respect to the anchoring member 102 ofthe first heart valve device 101 of the modular heart valve prosthesis100 (such as, but not limited to the brim 118, tissue engaging elements114, graft material 112, sealing component 128, etc.) may be includedand incorporated in the anchoring member 102 of the first heart valvedevice 401 of the modular heart valve prosthesis 400.

The valve support 404 of the first heart valve device 401 of the modularheart valve prosthesis 400 may be a generally tubular frame or stentthat supports the temporary prosthetic valve 406 within the interior ofthe valve support 404. In some embodiments, the valve support 404 may beany structure of a stent, including longitudinal posts, circumferentialstruts and crowns, and other structural features known to those skilledin the art. The valve support 404 may be similar in structure to thevalve support 404, except for the shape thereof. In particular, as canbe seen in FIGS. 4 and 6, the valve support 104 is generallycylindrical, whereas, as can be seen in FIGS. 13 and 15, the valvesupport 404 is generally reverse hourglass or biconic in shape. Inparticular, the valve support 404 includes a first diameter D_(i) at aninflow end thereof, a second diameter D_(c) in a central portionthereof, and a third diameter D_(o) at an outflow end thereof, whereinthe first and third diameters D_(i) and D_(o) are smaller than thesecond diameter D_(c).

In embodiments hereof, both the anchoring frame 102 and the valvesupport 404 of the first heart valve device 401 are self-expanding toreturn to a radially expanded state from a radially compressed state andmay be made from materials such as, but not limited to stainless steel,a pseudo-elastic metal such as a nickel titanium alloy (e.g. NITINOL),or a so-called super alloy, which may have a base metal of nickel,cobalt, chromium, or other metal. “Self-expanding” as used herein meansthat a structure/component has a mechanical memory to return to theradially expanded configuration or state as described herein. Thus, thefirst heart valve device 401 has a radially compressed configuration fordelivery within a delivery system and the radially expandedconfiguration for deployment within an annulus of the native heart valvesite.

As previously described, the first heart valve device 401 includes thetemporary prosthetic valve 406 within the interior of the valve support404. The temporary prosthetic valve 406 is configured as a one-way valveto allow blood flow in one direction and thereby regulate blood flowtherethrough. The temporary prosthetic valve 406 is capable of blockingflow in one direction to regulate flow therethrough via valve leaflets407 that may form a bicuspid or tricuspid replacement valve. Thetemporary prosthetic valve 406 is referred to as a temporary valvebecause the valve leaflets are made of relatively thin material suchthat the first heart valve device 401 may be radially compressed to asmaller diameter or profile radially compressed configuration fordelivery. Such a smaller diameter or profile is particularly useful formitral valve prostheses because a transseptal approach to the nativemitral valve requires a tight turning radius. A larger mitral valveprosthesis may have difficulty making the required turn in the radiallycompressed configuration. Thus, the valve leaflets 407 of the temporaryprosthetic valve 406 may be made of thin synthetic materials such as,but not limited to, polyester, polyethylene terephthalate (PET),polytetrafluoroethylene (PTFE), polyurethane, cloth materials, nylonblends, and polymeric materials. In a particular example, the valveleaflets 407 are formed of polyethylene terephthalate (PET) fabric. Thevalve leaflets have a thickness in the range of about 0.04 mm to about0.10 mm. In an embodiment, the valve leaflets 107 have a thickness ofapproximately 0.07 mm. The valve leaflets 407 are sutured or otherwisesecurely and sealingly attached to an inner circumference of the valvesupport 404 and/or a graft material (not shown) which encloses or linesthe valve support 404.

As noted above, it is desirable for the first heart valve device 401 tohave a small diameter or profile when in the radially compressedconfiguration. Therefore, as described above, the first heart valvedevice 401 includes a thin prosthetic valve 406 disposed within thevalve support 404, approximately 0.07 mm in thickness. However, such athin prosthetic valve 406 cannot serve as a long-term replacement valvefor the native mitral valve due to limited durability of such a thinfabric prosthetic valve. However, the prosthetic valve 406 can serve asa temporary or short term valve.

Thus, as described in more detail below, the first heart valve device401 with the temporary prosthetic valve 406 is delivered and deployed atthe native mitral valve. The second heart valve device 450, as shown inFIGS. 14 and 15, is thereafter delivered and deployed within the valvesupport 404 of the first heart valve device 401 to form the modularheart valve prosthesis 400. The second heart valve device 450 is thusseparate from the first heart valve device 401 until the second heartvalve device 450 is delivered to and deployed within the alreadydeployed first heart valve device 401.

The second heart valve device 450 may be generally tubular. The secondheart valve device 450 includes a valve support or frame 452 and asecond or permanent prosthetic valve 454 disposed within and coupled tothe frame 452. The second heart valve device 450 includes an inflow end458 and an outflow end 460. The second heart valve device 450 mayfurther include a skirt (not shown) coupled to the valve support 452.

The valve support 452 may be a stent or frame that supports theprosthetic valve 454 within the interior of the valve support 452. Thevalve support 452 may be any stent structure including components suchas, but not limited to, struts, bends/crowns, longitudinal bars, andother structural features known to those skilled in the art. The valvesupport 452 of the second valve device 450 may be similar to the valvesupport 452 of the embodiment of FIGS. 1-6 except that the valve support452 is generally cylindrical, as shown in FIG. 5, and the valve support452 has a reverse hourglass or biconic shape, as shown in FIGS. 14 and15. Thus, the valve support 452 includes a first diameter D_(2i) at theinflow end thereof, and second diameter D_(2c) at a central portionthereof, and the third diameter D_(2o) at the outflow end thereof, thefirst and third diameters D_(2i), D_(2o) being smaller than the seconddiameter D_(2c).

Thus, the valve support 452 of the second valve device 450 has a similarreverse hourglass shape as the valve support 404 of the first heartvalve device 401. The reverse hourglass shape of each valve support404/452 enables a more secure engagement between the valve support 452and the valve support 404 when the valve support 452 is deployed withinthe valve support 404, as shown in FIG. 15. The corresponding reversehourglass shapes enables the use of a self-expanding valve support 452with less of a likelihood of the valve support 452 of the second heartvalve device 450 moving or migrating after deployment within the valvesupport 404 than if the valve supports were cylindrical.

Further, although not shown in FIGS. 14 and 15, the valve support 452may also include a brim and/or barbs similar to the brim 390 and barbs392 described above with respect to the valve support 352.

To further enhance the engagement between the valve support 452 and thevalve support 404 when both are self-expanding, the valve support 452 ofthe second heart valve device 450 may be oversized with respect to thevalve support 404 of the first heart valve device 401. Oversizing thevalve support 452 of the second heart valve device 450 relative to thevalve support 404 of the first heart valve device 401 is described indetail above with respect the valve support 252 of the second heartvalve device 250 relative to the valve support 204 of the first heartvalve device 201 of the modular heart valve prosthesis 200. Therefore,that description is incorporated into the description of oversizing thevalve support 452 relative to the valve support 401 of the modular heartvalve prosthesis 400.

Similar to the second heart valve device 150 of the embodiment of FIGS.1-6, the second heart valve device 450 of the embodiment of FIGS. 13-15may include a skirt (not shown) coupled to the valve support 452. Theskirt may be one or more layers of a graft material. The graft materialof the skirt may be coupled to the valve support 452 to provide a moresecure engagement between the second heart valve device 450 and thevalve support 404 of the first heart valve device 401, and to preventparavalvular leaks between the second heart valve device 450 and valvesupport 404 of the first heart valve device 401. The skirt may be formedfrom a suitable natural or biological graft material such as pericardiumor another membranous tissue including, but not limited to intestinalsubmucosa. Alternatively, the skirt may be a low-porosity woven fabric,such as polyester, polyethylene terephthalate (PET), orpolytetrafluoroethylene (PTFE), which creates a one-way fluid passagewhen attached to the frame.

The delivery and deployment of the modular heart valve prosthesesdisclosed herein will now be described with respect to FIGS. 16-24.FIGS. 16-24 are sectional cut-away views of a heart HE illustrating atrans-septal method approach for delivering and deploying the modularheart valve prosthesis 100. Although FIGS. 16-24 show delivery anddeployment the modular heart valve prosthesis 100, the same method canbe used for delivering and deploying the modular heart valve prostheses200, 300, or 400.

FIGS. 16-20 show a delivery system 500 for delivering and deploying thefirst heart valve device 101 of the modular heart valve prosthesis 100.The delivery system 500 shown in schematically in FIGS. 16-20 can be anydelivery system capable of percutaneously delivering the first heartvalve device 101 to the location of a native mitral valve. Therefore,any details described with respect to the delivery system 500 areexamples only and not meant to be limiting. Further details of theparticular delivery system 500 may also be found in U.S. patentapplication Ser. No. 16/807,010, filed Mar. 2, 2020, the contents ofwhich are incorporated by reference herein in their entirety. It isunderstood that other delivery systems may be used to deliver and deploythe first heart valve device 101 and the second heart valve device 150.

With reference to FIG. 16, the delivery system 500 is shown after havingbeen introduced into the vasculature via a percutaneous entry pointtechnique, such as the Seldinger technique, and having been trackedthrough the vasculature and into the left atrium LA so that a distal tipcomponent 532 is positioned proximate the native mitral valve MV.Intravascular access to the right atrium may be achieved via apercutaneous access site to femoral vein, into the common iliac vein,through the inferior vena cava, and into the right atrium, or otherknown access routes as described in the background above. A guidewire GWis advanced via the route and is directed into the right atrium. Theguidewire GW traverses the right atrium and traverses through the atrialseptum with the aid of a trans-septal needle or a pre-existing hole,thereby entering the left atrium LA. Once the guidewire GW ispositioned, the percutaneous entry point and the trans-septal punctureare dilated to permit entry of a guide catheter GC into the left atriumLA. Thereafter, a delivery catheter 520 is advanced over the guidewireGW and through the guide catheter GC into the left atrium LA through thepunctured atrial septum and positioned proximate or upstream to thenative mitral valve MV. Although described as a transfemoral antegradeapproach for percutaneously accessing the mitral valve, the first heartvalve device 101 may be positioned within the desired area of the heartvia other different entry methods such as a trans-septal antegradeapproach via a thoracotomy for accessing the mitral valve. In addition,although described with the use of the guide catheter GC and theguidewire GW, in other embodiments the delivery catheter 520 may accessthe right atrium without the use of a guidewire and/or a guide catheter.

In FIG. 16, the distal portion of the delivery system 500 is shownpositioned in the left atrium LA with a capsule portion 530, including acapsule segment 542 of an outer shaft 522 and a distal shaft component534 of the distal tip component 532 in combination holding the firstheart valve device 101 in a radially compressed configuration. Withadditional reference to FIG. 16, and as will be understood by thoseknowledgeable in the pertinent art, the delivery catheter 520 includesother features such as, but not limited to, a handle, proximal shaftportion, and other catheter elements know to those skilled in the art.Further, some of the elements, such as but not limited to, the handleand some length of a proximal segment of the delivery catheter 520, areexposed externally of the patient for access by a clinician, even as thefirst heart valve device 101 has been advanced fully to the desiredtreatment site (e.g., left atrium LA) in the patient. By manipulatingthe handle of the delivery catheter 520 from outside the vasculature, aclinician may advance, retract, and remotely manipulate and steer thedistal portion of the delivery catheter 520 through the sometimestortuous intravascular path.

In a next delivery step shown in FIG. 17, the delivery catheter 520 isadvanced into proximity to and/or apposition within the annulus ANand/or leaflets of the native mitral valve MV. The delivery catheter 520is advanced until the first heart valve device 101 in the radiallycompressed configuration is centered at the native mitral valve MV.

Once the delivery catheter 520 is position such that the first heartvalve device 101 is positioned within the native mitral valve MV, anactuator of the catheter 520 may be actuated to proximally retract theouter shaft 522, as shown in FIG. 18. Proximal retraction of the outershaft 522 causes the capsule segment 542 of the outer shaft 522 to beproximally retracted such that the capsule segment 542 does not encircleor retain the anchoring member 102 of the first heart valve device 101(which includes at least the brim 118 of the first heart valve device101). Proximal retraction of the capsule segment 542 exposes andreleases the anchoring member 102 of the first heart valve device,thereby enabling at least the brim 118 of the anchoring member 102 toradially expand, as shown in FIG. 18. In addition to radial expansion ofthe brim 118, the remainder of the anchoring member 102 is also releasedfrom the capsule segment 242 and radially expands relative to the innervalve support 104, which remains radially compressed within a capsulesegment 548 of an intermediate shaft 526. Retraction of the capsulesegment 542 and subsequent deployment of the anchoring member 102 may beconsidered a first stage of deployment of a deployment process for thefirst heart valve device 101. After proximal retraction of the capsulesegment 542, the capsule segment 548 of the intermediate shaft 526maintains the valve support 104 in the radially compressed state and thedistal shaft component 534 of the distal tip component 532 maintains adistal portion of the first heart valve device 101 in the radiallycompressed state.

With the anchoring member 102 released from the capsule segment 542 ofthe outer shaft 522, the delivery catheter 520 in some embodiments maybe manipulated to properly seat the first heart valve prosthesis device101. For example, and not by way of limitation, the delivery catheter520 may be pushed distally such that the brim 118 of the anchoringmember 102 seats against the atrial side of the mitral valve annulus AN.

With reference to FIG. 19, once the first heart valve device 101 isproperly positioned and the anchoring member 102 has been released fromthe capsule segment 542, an actuator of the catheter 520 may be actuatedto proximally retract the intermediate shaft 526. The intermediate shaft526 is retracted proximally such that a capsule segment 548 of theintermediate shaft 526 is retracted proximally such that the valvesupport 104 of the first heart valve device 101 is no longer retainedwithin the capsule segment 548. Accordingly, the valve support 104radially expands to the radially expanded state. Retraction of thecapsule segment 548 and subsequent deployment of the valve support 104may be considered a second stage of the deployment process for the firstheart valve device 101. After proximal retraction of the capsule segment548, the distal shaft component 534 of the distal tip component 532maintains the distal portion of the heart valve device 101 in theradially compressed state.

Referring next to FIG. 20, once the anchoring member 102 and the innervalve support 104 are each positioned and deployed within the nativemitral valve MV, an actuator of the delivery catheter 520 may beactuated such that an inner shaft 524 is advanced in a distal direction.The inner shaft 524 is advanced distally such that the distal shaftcomponent 534 of the distal tip component 532 is also advanced distallyto uncover or release the distal or outflow portion of the first heartvalve device 101, thereby enabling the outflow portion of the firstheart valve device 101 to return to a radially expanded state within thenative mitral valve MV. Further, release of the outflow portion of thefirst heart valve device 101 enables complete expansion of the anchoringmember 102 and the valve support 104 to the radially expanded state.

Following delivery, placement and implantation of first heart valvedevice 101 within the mitral valve MV (or other desired valve location),the delivery catheter 520 of the delivery system 500 is removed from theheart and out of the body of the patient, as would be understood by oneof skill in the art. The deployed first heart valve device 101 with thedelivery catheter 520 removed (but the guidewire GW remaining in place)is shown in FIG. 21.

After delivery and deployment of the first heart valve device 101, asecond delivery catheter 620 with the second heart valve device 150disposed within a capsule 642 of an outer shaft 622 thereof is deliveredto within the valve support 104 of the first heart valve device, asshown in FIG. 22. During the time it takes to remove the first deliverycatheter 520 from the vasculature, and insert and track the seconddelivery catheter 620 the native mitral valve, the temporary prostheticvalve 106 of the first heart valve device 101 operates to maintain bloodflow control through the mitral valve. Although the description of FIGS.21-24 describes delivering and deploying the second heart valve device150, it is understood that the method may apply equally to the secondheart valve devices 250, 350, and 450. Further, as described in FIGS.21-24, the second heart valve device is self-expanding. However, aballoon-expandable second heart valve device 150 may be used. Using aballoon-expandable second heart valve device 150, the second deliverycatheter will be a balloon catheter, as known to those skilled in theart.

With the second delivery catheter 620 at the desired location, thecapsule 642 is retracted proximally by retracting the outer shaft 622,thereby exposing the second heart valve device 150 and enabling thesecond heart valve device 150 to self-expand to the radially expandedconfiguration, as shown in FIG. 23. Those skilled in the art wouldunderstand that if the second heart valve device 150 is balloonexpandable, this step of the method would comprise delivering inflationfluid to within a balloon of a balloon catheter, thereby radiallyexpanding the balloon and the second heart valve device disposedthereon.

With the second heart valve device 150 radially expanded within thevalve support 104 of the first heart valve device 101, the seconddelivery catheter 620 and the guidewire GW may be removed from thepatient, thereby leaving the modular heart valve prosthesis 100 deployedwithin the mitral valve MV, as shown in FIG. 24.

While various embodiments have been described above, it should beunderstood that they have been presented only as illustrations andexamples of the present invention, and not by way of limitation. It willbe apparent to persons skilled in the relevant art that various changesin form and detail can be made therein without departing from the spiritand scope of the invention. Thus, the breadth and scope of the presentinvention should not be limited by any of the above-described exemplaryembodiments but should be defined only in accordance with the appendedclaims and their equivalents. It will also be understood that eachfeature of each embodiment discussed herein can be used in combinationwith the features of any other embodiment.

What is claimed:
 1. A modular heart valve prosthesis comprising: a firstheart valve device including, a first valve support including a firstprosthetic valve disposed within the valve support, the first prostheticvalve comprising synthetic fabric leaflets having a first thickness, andan anchoring frame surrounding the first valve support and coupled tothe first valve support, the anchoring frame including a first portionand a second portion; and a second heart valve device including a secondvalve support and a second prosthetic valve disposed within the secondvalve support, the second prosthetic valve comprising tissue leafletshaving a second thickness, wherein the second thickness is greater thanthe first thickness, wherein in a first configuration the second heartvalve device is separate from the first heart valve device and in asecond configuration the second heart valve device is disposed withinthe first valve support of the first heart valve device.
 2. The modularheart valve prosthesis of claim 1, wherein the first heart valve deviceis self-expanding, and wherein the second heart valve device is balloonexpandable.
 3. The modular valve prosthesis of claim 1, wherein thefirst heart valve device is self-expanding, and wherein the second heartvalve device is self-expanding.
 4. The modular heart valve prosthesis ofclaim 1, wherein the synthetic fabric leaflets of the first prostheticvalve are formed from material selected from the group consisting ofpolyester, polyethylene terephthalate (PET, e.g. DACRON),polytetrafluoroethylene (PTFE), polyurethane, cloth materials, nylonblends, and polymeric materials.
 5. The modular heart valve prosthesisof claim 1, wherein the tissue leaflets of the second prosthetic valveare formed from material selected from the group consisting of bovinepericardium tissue and porcine pericardium tissue.
 6. The modular heartvalve prosthesis of claim 1, wherein the first thickness is about 0.04mm to about 0.10 mm.
 7. The modular heart valve prosthesis of claim 6,wherein the first thickness is about 0.07 mm.
 8. The modular heart valveprosthesis of claim 1, wherein the second thickness is in the range ofabout 0.35 mm to about 0.5 mm.
 9. The modular heart valve prosthesis ofclaim 1, wherein the first heart valve device has a crimped diameter ofapproximately 27 Fr.
 10. The modular heart valve prosthesis of claim 9,wherein the second heart valve device has a crimped diameter ofapproximately 14 Fr.
 11. The modular heart valve prosthesis of claim 1,wherein the first valve support and the second valve support are bothgenerally cylindrical.
 12. The modular valve prosthesis of claim 1,wherein the first valve support has an hourglass shape with a firstdiameter at an inflow portion thereof, a second diameter at a centralportion thereof, and a third diameter at an outflow portion thereof,wherein the first and third diameters are each larger than the seconddiameter, and wherein the second valve support has a correspondinghourglass shape.
 13. The modular valve prosthesis of claim 1, whereinthe first valve support has a reverse hourglass shape with a firstdiameter at an inflow portion thereof, a second diameter at a centralportion thereof, and a third diameter at an outflow portion thereof,wherein the first and third diameters are each smaller than the seconddiameter, and wherein the second valve support has a correspondingreverse hourglass shape.
 14. The modular valve prosthesis of claim 1,wherein the second valve support includes a brim at an inflow endthereof, wherein the brim is parallel to a central longitudinal axis ofthe second valve support with the second heart valve device in aradially compressed configuration, wherein the brim is disposed radiallyoutward at a non-zero angle with respect to the central longitudinalaxis with the second heart valve device in a radially expandedconfiguration, and wherein in the second configuration of the secondheart valve device, the brim is proximal of an inflow end of the firstvalve support.
 15. The modular valve prosthesis of claim 14, wherein thenon-zero angle is between 30 and 90 degrees.
 16. The modular valveprosthesis of claim 1, wherein the second heart valve device furtherincludes barbs extending radially outward from an outer surface of thesecond valve support such that with the second heart valve device in thesecond configuration, the barbs engage the first valve support.
 17. Amethod of delivering and deploying a modular heart valve prosthesiscomprising the steps of: delivering a first heart valve device in aradially compressed configuration to a site of a native heart valve, thefirst heart valve device including a first valve support including afirst prosthetic valve comprising synthetic fabric leaflets disposedwithin the valve support and an anchoring frame surrounding the firstvalve support and coupled to the first valve support; deploying thefirst heart valve device by radially expanding the first heart valvedevice such that the anchoring frame is disposed within native leafletsof the native heart valve; after deploying the first heart valve device,delivering a second heart valve device in a radially compressedconfiguration to within the first valve support, the second heart valvedevice comprising a second valve support and a second prosthetic valvecomprising tissue leaflets disposed within the second valve support; anddeploying the second heart valve device by radially expanding the secondvalve support such that the second valve support engages the firstprosthetic valve and the first valve support.
 18. The method of claim17, wherein the step of deploying the first heart valve device comprisesreleasing the first heart valve device from a sheath such that the firstheart valve device self-expands.
 19. The method of claim 18, wherein thestep of deploying the second heart valve device comprises radiallyexpanding the second valve support with a balloon.
 20. The method ofclaim 17, wherein the first heart valve device is disposed in a firstcatheter for the step of delivering the first heart valve device. 21.The method of claim 20, wherein after the step of deploying the firstheart valve device, the first catheter is withdrawn from the site of thenative heart valve.
 22. The method of claim 21, wherein after the stepof withdrawing the first catheter, the second heart valve device isdisposed in a second catheter for the step of delivering the secondheart valve device to within the first valve support.